Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development

Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…

Nov 20^th • 12 mins read

Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects

Complex E–R relationship, immuno-oncology, single-dose PK model, therapeutic monoclonal antibodies

Recent data from immuno-oncology clinical studies show that the exposure–response (E–R) relationship for therapeutic monoclonal antibodies (mAbs) is often confounded by various factors. The complex interplay involves patient characteristics, disease, drug exposure, clearance, and…

Jun 18^th • 30 mins read

Biosimilars: what the oncologist should know

biosimilars, extrapolation, monoclonal antibodies, oncologic biosimilars

As originator biologic medicines lose patent protection, biopharmaceutical companies are developing biosimilars. Biosimilars are similar versions of costly and complex therapies aimed at providing more affordable treatment options. Many biosimilars are now approved worldwide, with several m…

Dec 18^th • 25 mins read

A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation

Biosimilars, interchangeability, extrapolation, immunogenicity

Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared to traditional chemotherapy. The cost of biologic drugs is high, leading to increased healthcare expenses. This mirror…

Aug 3^rd • 10 mins read